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Status unknownNCT01549093Updated Mar 24, 2015

Endostar Continued Pumping Into Vein Combining With Gemcitabine-Carboplatin to Treat Non-Small Cell Lung Cancer (NSCLC)

A Phase 2 interventional study of Gemcitabine,Carboplatin,Endostar and Gemcitabine(G) Carboplatin(C) Endostar in Non-small Cell Lung Cancer, sponsored by Hunan Province Tumor Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-03-24.

Sponsored by Hunan Province Tumor Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether Endostar with Gemcitabine-Carboplatin are more effective than Gemcitabine-Carboplatin alone in the treatment of Non-Small Cell Lung Cancer (NSCLC),and about Endostar ,Compared with intravenous, Continued vein-pumping maby is a more effective way.

Read the detailed description

Endostar have anti-tumor activity by against vascular endothelial growth factor for initial treatment. This study was designed to evaluate the safety and efficacy of Endostar Continued vein-pumping Combining with Gemcitabine-Carboplatin (GC)chemotherapy in patients with NSCLC,and seeking for more effective injection.

Methods:

In this randomized, open label, 90 patients are planned to be enrolled at random into 3 arms(1:1:1): Experimental: Endostar -Continued Pumping into+Gemcitabine-Carboplatin(GC),Active Comparator: Endostar -injecting into +Gemcitabine-Carboplatin(GC),Active Comparator: Gemcitabine-Carboplatin(GC),

02

Conditions studied

  • Non-small Cell Lung Cancer

Keywords

  • Non-small cell lung cancer
  • Endostar
  • Continued Pumping into
  • Gemcitabine
  • Carboplatin
03

In context

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's planned enrollment of 90 is above the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Hunan Province Tumor Hospital is the lead sponsor of 75 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Histologically or cytologically diagnosed NSCLC;
  2. primary treatment,inoperable stage III/IV NSCLC;
  3. Age of 18-70years; Gender Not Required;

  4. Adequate hematologic, renal, and hepatic function ,Specific index as follows:

    liver function: S-Bilirubin ≤1.5 ULN ; Transaminase≤2 ULN. renal function: S-Creatinine ≤1.2 ULN; blood urea nitrogen ≤1.2 ULN . ULN: upper normal limit. Marrow Hemopoietic Function: WBC≥4.0×10\^9/l, ANC≥2.0×10\^9/l platelet count ≥100×10\^9/l, Hb≥100 g/l;

  5. ECOG PS 0-2,Life expectancy ≥ 3 months; endure more than two cycle chemotherapy;
  6. The patients have explicit lung tumor lesions and the lesions were measurable; (According to the standard of RECIST1.1, they should have at least one of accurately measurable lesions with the largest diameter ≥ 10mm by spiral CT, MRI);
  7. No history of serious drug allergy;
  8. Informed consent should be obtained before treatment.

Exclusion criteria

Exclusion Criteria:

  1. Symptomatic brain metastases with cognitive disorder,bone metastases with complications;
  2. Major organ dysfunction and Serious Heart Disease( congestive heart-failure,incontrollable high-risk arrhythmia,unstable angina, valvular disease, myocardial infarct and Resistant hypertension,);
  3. Serious complications and investigator consider it is unsuited enrolling;
  4. Pregnant or lactating women;
  5. Allergic to research drug;
  6. participating in other experimental trials and receive the treatment in four weeks;
  7. The position that is for observing curative effect have a radiotherapy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Endostar -Continued Pumping into+GC

    Endostar that is Continued Pumping into vein Combining With Gemcitabine -Carboplatin

    Drug: Gemcitabine,Carboplatin,Endostar

  • Active comparator
    Endostar -injecting into +GC

    Endostar that is injecting into vein with Gemcitabine -Carboplatin

    Drug: Gemcitabine(G) Carboplatin(C) Endostar

  • Active comparator
    GC

    Gemcitabine -Carboplatin

    Drug: Gemcitabine(G) Carboplatin(C)

Interventions

  • DrugGemcitabine,Carboplatin,Endostar

    Drug pages: Gemcitabine · Carboplatin · Endostar protein

    Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2\*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.

  • DrugGemcitabine(G) Carboplatin(C) Endostar

    Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles

  • DrugGemcitabine(G) Carboplatin(C)

    Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles

06

What researchers measure

Primary outcomes

  1. Progression free survival (PFS)

    Time frame: two years

Secondary outcomes

  1. Overall survival (OS)

    Time frame: two years

  2. Clinical benefit rate (CBR)

    Time frame: two years

  3. The level change of CECs,VEGF,TSP-1,VEGFR,P1GF,MVD in blood.

    Time frame: two years

  4. adverse reaction

    Time frame: two years

  5. Time to progression(TTP)

    Time frame: two years

07

Study locations

1 of 1 sites recruiting
  • HuNan province tumor hospital
    Changsha, Hunan 410000, China
    • Jianhua Chen, master · Contact · cjh_1000@163.com · 0086-731-89762221
    • Jianhua Chen, master · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01549093
Lead sponsor
Hunan Province Tumor Hospital
Responsible party
Jianhua Chen (professer, Hunan Province Tumor Hospital) — Principal investigator
First posted
Mar 8, 2012
Start date
Aug 2011
Primary completion
Jul 2016 (estimated)
Completion
Oct 2016 (estimated)
Last update
Mar 24, 2015

Study contacts

Jianhua Chen, master
Contact
cjh_1000@163.com
0086-731-89762221
Jianhua Chen, master
principal investigator · Hunan Province Tumor Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Gemcitabine · Carboplatin · Endostar protein

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